A Study to Evaluate the Effect of Mechanical Ventilation on the Inferior Vena Cava Collapsibility Index (IVCCI)
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | May 26, 2010 | ||||
| Last Updated Date | March 21, 2013 | ||||
| Start Date ICMJE | October 2009 | ||||
| Primary Completion Date | February 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Determine the effect of an increase in positive end-expiratory pressure on intrathoracic pressure variables in patients with acute respiratory failure. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
|
||||
| Original Primary Outcome Measures ICMJE |
Determine the effect of an increase in PEEP on intrathoracic pressure variables in patients with acute respiratory failure. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
|
||||
| Change History | Complete list of historical versions of study NCT01136109 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE |
|
||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study to Evaluate the Effect of Mechanical Ventilation on the Inferior Vena Cava Collapsibility Index | ||||
| Official Title ICMJE | A Prospective Pilot Study to Evaluate the Effect of Mechanical Ventilation on the Inferior Vena Cava Collapsibility Index | ||||
| Brief Summary | Previous research has shown that the Inferior Vena Cava Collapsibility Index (IVCCI) can be used to assess volume status. One limitation of the previous work is that changes in intra-thoracic pressure can influence this measurement, and the magnitude of this effect has never been described. The investigators aim is to correlate the degree of change in IVCCI with the set degree of change in intra-thoracic pressure in a heterogeneous population of critically ill patients. |
||||
| Detailed Description | Initially eligible patients will be those admitted to the OSU MICU and 8ICU within the prior 48 hours. These patients will be screened for predetermined exclusion criteria. Eligible patients will have their IVCCI measured and baseline peak and plateau pressures noted. For those patients meeting a second set of criteria, a common ventilator maneuver will be preformed. The positive end-expiratory pressure will be increased by 5-10 cm/H20 pressure. This procedure will be aborted if ANY safety criteria are exceeded. During the interval, the IVCCI will be re-measured, the ventilator settings will be recorded, and the ventilator will be return to the initial settings. Since changes of these same magnitude are made daily in clinical practice, the risks to the patients in this study will be minimal and no more than that experienced in the course of usual care. |
||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | InpatientSample |
||||
| Condition ICMJE | Respiratory Failure | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 32 | ||||
| Completion Date | February 2013 | ||||
| Primary Completion Date | February 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria for ventilator changes:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01136109 | ||||
| Other Study ID Numbers ICMJE | 2009H0143 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Naeem Ali, MD, The Ohio State University | ||||
| Study Sponsor ICMJE | Naeem Ali, MD | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Ohio State University | ||||
| Verification Date | March 2013 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||